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CompletedPhase 2 / Phase 3

Esketamine and Perioperative Depressive Symptoms

NCT04425473 · Beijing Tiantan Hospital

Closed to entry
Status
Not accepting participants
Phase 2 / Phase 3
Phase
435
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

Perioperative depressive symptoms (PDS) are common in population undergoing surgery, and this would be sharpened especially for complicated, high-risk major surgery. However, None of treatments could resolve this clinical problem during limited perioperative period. The remarkable effects of ketamine on treatment resistant depression have been verified by several clinical trials and the enantiomer S-ketamine (esketamine) showed similar antidepressant efficacy with better safety in recent studies. The efficacy and safety of esketamine administrated intra-operatively for PDS will be verified in this study. Other secondary outcomes such as anxiety, postoperative pain and psychiatric symptoms will also be investigated.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Depressive symptoms remission

    Measured over Postoperative 3-day

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Patient undergoing elective major surgery * Ages between 18 and 65 years old * Moderate to severe depressive symptoms ( the Patient Health Questionnaire-9 scores equal to or more than 10 and Montgomery-Åsberg Depression Rating Scale scores equal to or more than 22 ) * Signed informed consent Exclusion Criteria: * had aphasia or any conditions that prevented mental health assessments, * had a history of psychotic or bipolar disorder, * had a comorbidity that affected hormone levels, * required prolonged postoperative mechanical ventilation, * had received treatment with antidepressants within 2 weeks prior to the screening, * had a body mass index greater than 30 kg/m2 and a Child-Pugh score greater than 6 points. * had made repeated suicide attempts (as assessed by the 12-item Quick Inventory of Depressive Symptomatology scores less than 3), * had experienced adverse reactions to ketamine or esketamine, * had known drug use disorders, * pregnant or breastfeeding

Where

1 study site

FacilityCityRegionCountry
Beijing Tiantan Hospital, Capital Medical UniversityBeijingChina

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT04425473 on ClinicalTrials.gov →

Last updated in the registry 2025-08-01. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits